NovoRapid (Insulin Aspart) PDF

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
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1. NAME OF THE MEDICINAL PRODUCT
NovoRapid 100 units/ml solution for injection in vial

NovoRapid Penfill 100 units/ml solution for injection in cartridge
NovoRapid FlexPen 100 units/ml solution for injection in pre-filled pen
NovoRapid InnoLet 100 units/ml solution for injection in pre-filled pen
NovoRapid FlexTouch 100 units/ml solution for injection in pre-filled pen
NovoRapid PumpCart 100 units/ml solution for injection in cartridge
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
NovoRapid vial
1 ml solution contains 100 units insulin aspart* (equivalent to 3.5 mg). 1 vial contains 10 ml
equivalent to 1,000 units.
NovoRapid Penfill
1 ml solution contains 100 units insulin aspart* (equivalent to 3.5 mg). 1 cartridge contains 3 ml
equivalent to 300 units.
NovoRapid FlexPen/NovoRapid InnoLet/NovoRapid FlexTouch

1 ml solution contains 100 units insulin aspart* (equivalent to 3.5 mg). 1 pre-filled pen contains 3 ml
NovoRapid PumpCart
1 ml solution contains 100 units insulin aspart* (equivalent to 3.5 mg). 1 cartridge contains 1.6 ml
*Insulin aspart is produced in Saccharomyces cerevisiae by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection.
The solution is clear, colourless and aqueous.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
NovoRapid is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1
year and above.
4.2 Posology and method of administration
Posology
The potency of insulin analogues, including insulin aspart, is expressed in units, whereas the potency
of human insulin is expressed in international units.
NovoRapid dosing is individual and determined in accordance with the needs of the patient. It should
normally be used in combination with intermediate-acting or long-acting insulin.
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Moreover NovoRapid can be used for continuous subcutaneous insulin infusion (CSII) in pump
systems.
It can also be administered intravenously by physicians or other healthcare staff if applicable.
Blood glucose monitoring and insulin dose adjustments are recommended to achieve optimal
glycaemic control.
The individual insulin requirement in adults and children is usually between 0.5 and 1.0 unit/kg/day.
In a basal-bolus treatment regimen 50-70% of this requirement may be provided by NovoRapid and
the remainder by intermediate-acting or long-acting insulin.
Adjustment of dose may be necessary if patients undertake increased physical activity, change their
usual diet or during concomitant illness.
Special populations
Elderly ( 65 years old)

NovoRapid can be used in elderly patients.
In elderly patients, glucose monitoring should be intensified and the insulin aspart dose adjusted on an
individual basis.
Renal and hepatic impairment

Renal or hepatic impairment may reduce the patients insulin requirements.
In patients with renal or hepatic impairment, glucose monitoring should be intensified and the insulin
aspart dose adjusted on an individual basis.
Paediatric population
NovoRapid can be used in children and adolescents aged 1 year and above in preference to soluble
human insulin when a rapid onset of action might be beneficial, for example, in the timing of the
injections in relation to meals (see sections 5.1 and 5.2).
The safety and efficacy of NovoRapid in children below 1 year of age have not been established.
No data are available.
Transfer from other insulin medicinal products
When transferring from other insulin medicinal products, adjustment of the NovoRapid dose and the
dose of the basal insulin may be necessary. NovoRapid has a faster onset and a shorter duration of
action than soluble human insulin. When injected subcutaneously into the abdominal wall, the onset of
action will occur within 10-20 minutes of injection. The maximum effect is exerted between 1 and
3 hours after the injection. The duration of action is 3 to 5 hours.
Close glucose monitoring is recommended during the transfer and in the initial weeks thereafter (see
section 4.4).
Method of administration
NovoRapid is a rapidacting insulin analogue.

NovoRapid is administered subcutaneously by injection in the abdominal wall, the thigh, the upper
arm, the deltoid region or the gluteal region. Injection sites should always be rotated within the same
region in order to reduce the risk of lipodystrophy. Subcutaneous injection in the abdominal wall
ensures a faster absorption than other injection sites. Compared to soluble human insulin the faster
onset of action of NovoRapid is maintained regardless of the injection site. The duration of action will
vary according to the dose, injection site, blood flow, temperature and level of physical activity.
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Due to the faster onset of action, NovoRapid should generally be given immediately before a meal.
When necessary NovoRapid can be given soon after a meal.
Continuous Subcutaneous Insulin Infusion (CSII)

NovoRapid may be used for CSII in pump systems suitable for insulin infusion. CSII should be
administered in the abdominal wall. Infusion sites should be rotated.
When used with an insulin infusion pump, NovoRapid should not be mixed with any other insulin
medicinal products.
Patients using CSII should be comprehensively instructed in the use of the pump system and use the
correct reservoir and tubing for the pump (see section 6.6). The infusion set (tubing and cannula)
should be changed in accordance with the instructions in the product information supplied with the
infusion set.
Patients administering NovoRapid by CSII must have an alternative insulin delivery method available
in case of pump system failure.
Intravenous use
If necessary, NovoRapid can be administered intravenously which should be carried out by physicians
or other healthcare staff.
For intravenous use, infusion systems with NovoRapid 100 units/ml at concentrations from
0.05 unit/ml to 1.0 unit/ml insulin aspart in the infusion fluids 0.9% sodium chloride, 5% dextrose or
10% dextrose including 40 mmol/l potassium chloride using polypropylene infusion bags, are stable at
room temperature for 24 hours.
Although stable over time, a certain amount of insulin will be initially adsorbed to the material of the
infusion bag. Monitoring of blood glucose is necessary during insulin infusion.
For detailed user instructions, please refer to the package leaflet.
NovoRapid vial
Administration with a syringe
NovoRapid vials are for use with insulin syringes with the corresponding unit scale. See also section
6.2.
NovoRapid Penfill
Administration with an insulin delivery system
NovoRapid Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine
or NovoTwist needles.
NovoRapid FlexPen
Administration with FlexPen
NovoRapid FlexPen is a pre-filled pen (colour-coded) designed to be used with NovoFine or
NovoTwist disposable needles up to a length of 8 mm. FlexPen delivers 1-60 units in increments of
1 unit.
NovoRapid InnoLet
Administration with InnoLet
NovoRapid InnoLet is a pre-filled pen designed to be used with NovoFine or NovoTwist disposable
needles up to a length of 8 mm. InnoLet delivers 1-50 units in increments of 1 unit.
NovoRapid FlexTouch
Administration with FlexTouch
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NovoRapid FlexTouch is a pre-filled pen (colour-coded) designed to be used with NovoFine or
NovoTwist disposable needles up to a length of 8 mm. FlexTouch delivers 1-80 units in increments of
1 unit.
NovoRapid PumpCart
Administration via Continuous Subcutaneous Insulin Infusion (CSII)
NovoRapid PumpCart is only for use with an insulin infusion pump system designed to be used with
this cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps.
CSII should be administered in the abdominal wall. Infusion sites should be rotated.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients (see section 6.1).
4.4 Special warnings and precautions for use
Before travelling between different time zones, the patient should seek the doctors advice since this
may mean that the patient has to take the insulin and meals at different times.
NovoRapid PumpCart
Misuse of NovoRapid PumpCart
this cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps. It must not be used with
other devices not designed for NovoRapid PumpCart, as this may result in incorrect insulin dosing and
subsequent hyper- or hypoglycaemia.
Hyperglycaemia
Inadequate dosing or discontinuation of treatment, especially in type 1 diabetes, may lead to

hyperglycaemia and diabetic ketoacidosis. Usually the first symptoms of hyperglycaemia develop
gradually over a period of hours or days. They include thirst, increased frequency of urination, nausea,
vomiting, drowsiness, flushed dry skin, dry mouth, loss of appetite as well as acetone odour of breath.
In type 1 diabetes, untreated hyperglycaemic events eventually lead to diabetic ketoacidosis, which is
potentially lethal.
Hypoglycaemia
Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia.

Especially in children, care should be taken to match insulin doses (especially in basal-bolus regimens)
with food intake, physical activities and current blood glucose level in order to minimise the risk of
hypoglycaemia.
Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement. In case
of hypoglycaemia or if hypoglycaemia is suspected NovoRapid must not be injected. After
stabilisation of patients blood glucose adjustment of the dose should be considered (see sections 4.8
and 4.9).
Patients whose blood glucose control is greatly improved, e.g. by intensified insulin therapy, may
experience a change in their usual warning symptoms of hypoglycaemia, and should be advised
accordingly. Usual warning symptoms may disappear in patients with longstanding diabetes.
A consequence of the pharmacodynamics of rapid-acting insulin analogues is that if hypoglycaemia

occurs, it may occur earlier after an injection when compared with soluble human insulin.
Since NovoRapid should be administered in immediate relation to a meal, the rapid onset of action
should be considered in patients with concomitant diseases or treatment where a delayed absorption of
food might be expected.
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Concomitant illness, especially infections and feverish conditions, usually increases the patients
insulin requirements. Concomitant diseases in the kidney, liver or affecting the adrenal, pituitary or
thyroid gland can require changes in the insulin dose.
When patients are transferred between different types of insulin medicinal products, the early warning
symptoms of hypoglycaemia may change or become less pronounced than those experienced with
their previous insulin.
Transfer from other insulin medicinal products
Transferring a patient to another type or brand of insulin should be done under strict medical
supervision. Changes in strength, brand (manufacturer), type, origin (animal, human insulin or human
insulin analogue) and/or method of manufacture (recombinant DNA versus animal source insulin) may
result in the need for a change in dose. Patients transferred to NovoRapid from another type of insulin
may require an increased number of daily injections or a change in dose from that used with their
usual insulin medicinal products. If an adjustment is needed, it may occur with the first dose or during
the first few weeks or months.
Injection site reactions
As with any insulin therapy, injection site reactions may occur and include pain, redness, hives,
inflammation, bruising, swelling and itching. Continuous rotation of the injection site within a given
area reduces the risk of developing these reactions. Reactions usually resolve in a few days to a few
weeks. On rare occasions, injection site reactions may require discontinuation of NovoRapid.
Combination of NovoRapid with pioglitazone
Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin,
especially in patients with risk factors for development of cardiac heart failure. This should be kept in
mind if treatment with the combination of pioglitazone and NovoRapid is considered. If the
combination is used, patients should be observed for signs and symptoms of heart failure, weight gain
and oedema. Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs.
Avoidance of accidental mix-ups/medication errors
Patients must be instructed to always check the insulin label before each injection to avoid accidental
mix-ups between NovoRapid and other insulin products.
Insulin antibodies
Insulin administration may cause insulin antibodies to form. In rare cases, the presence of such insulin
antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or
hypoglycaemia.
4.5 Interaction with other medicinal products and other forms of interaction
A number of medicinal products are known to interact with the glucose metabolism.
The following substances may reduce the patient's insulin requirements:

Oral antidiabetic medicinal products, monoamine oxidase inhibitors (MAOI), beta-blockers, angiotensin
converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and sulphonamides.
The following substances may increase the patients insulin requirements:

Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone
and danazol.
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Beta-blockers may mask the symptoms of hypoglycaemia.
Octreotide/lanreotide may either increase or decrease the insulin requirement.
Alcohol may intensify or reduce the hypoglycaemic effect of insulin.
4.6 Fertility, pregnancy and lactation
Pregnancy
NovoRapid (insulin aspart) can be used in pregnancy. Data from two randomised controlled clinical
trials (322 and 27 exposed pregnancies) do not indicate any adverse effect of insulin aspart on
pregnancy or on the health of the foetus/newborn when compared to human insulin (see section 5.1).
Intensified blood glucose control and monitoring of pregnant women with diabetes (type 1 diabetes,
type 2 diabetes or gestational diabetes) are recommended throughout pregnancy and when
contemplating pregnancy. Insulin requirements usually fall in the first trimester and increase
subsequently during the second and third trimester. After delivery, insulin requirements normally
return rapidly to pre-pregnancy values.
Breast-feeding
There are no restrictions on treatment with NovoRapid during breast-feeding. Insulin treatment of the
nursing mother presents no risk to the baby. However, the NovoRapid dose may need to be adjusted.
Fertility
Animal reproduction studies have not revealed any differences between insulin aspart and human
insulin regarding fertility.
4.7 Effects on ability to drive and use machines
The patients ability to concentrate and react may be impaired as a result of hypoglycaemia. This may
constitute a risk in situations where these abilities are of special importance (e.g. driving a car or
operating machinery).
Patients should be advised to take precautions to avoid hypoglycaemia while driving. This is
particularly important in those who have reduced or absent awareness of the warning signs of
hypoglycaemia or have frequent episodes of hypoglycaemia. The advisability of driving should be
considered in these circumstances.
4.8 Undesirable effects
Summary of the safety profile
Adverse reactions observed in patients using NovoRapid are mainly due to the pharmacologic effect of
insulin.
The most frequently reported adverse reaction during treatment is hypoglycaemia. The frequencies of
hypoglycaemia vary with patient population, dose regimens and level of glycaemic control (see
section 4.8, Description of selected adverse reactions).
At the beginning of the insulin treatment, refraction anomalies, oedema and injection site reactions
(pain, redness, hives, inflammation, bruising, swelling and itching at the injection site) may occur.
These reactions are usually of transitory nature. Fast improvement in blood glucose control may be
associated with acute painful neuropathy, which is usually reversible. Intensification of insulin therapy
with abrupt improvement in glycaemic control may be associated with temporary worsening of
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diabetic retinopathy, while long-term improved glycaemic control decreases the risk of progression of
diabetic retinopathy.
Tabulated list of adverse reactions
Adverse reactions listed below are based on clinical trial data and classified according to MedDRA
frequency and System Organ Class. Frequency categories are defined according to the following
convention: Very common ( 1/10); common ( 1/100 to < 1/10); uncommon ( 1/1,000 to < 1/100);
rare ( 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the
available data).
Immune system disorders Uncommon Urticaria, rash, eruptions
Very rare Anaphylactic reactions*
Metabolism and nutrition Very common Hypoglycaemia*

disorders
Nervous system disorders Rare Peripheral neuropathy (painful neuropathy)
Eye disorders Uncommon Refraction disorders
Uncommon Diabetic retinopathy
Skin and subcutaneous tissue Uncommon Lipodystrophy*

disorders
General disorders and Uncommon Injection site reactions
administration site
Uncommon Oedema
conditions
* see section 4.8, Description of selected adverse reactions.
Description of selected adverse reactions
Anaphylactic reactions:
The occurrence of generalised hypersensitivity reactions (including generalised skin rash, itching,
sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation and
reduction in blood pressure) is very rare but can potentially be life threatening.
Hypoglycaemia:
The most frequently reported adverse reaction is hypoglycaemia. It may occur if the insulin dose is too
high in relation to the insulin requirement. Severe hypoglycaemia may lead to unconsciousness and/or
convulsions and may result in temporary or permanent impairment of brain function or even death.
The symptoms of hypoglycaemia usually occur suddenly. They may include cold sweats, cool pale
skin, fatigue, nervousness or tremor, anxiousness, unusual tiredness or weakness, confusion, difficulty
in concentration, drowsiness, excessive hunger, vision changes, headache, nausea and palpitation.
In clinical trials, the frequency of hypoglycaemia varied with patient population, dose regimens and
level of glycaemic control. During clinical trials the overall rates of hypoglycaemia did not differ
between patients treated with insulin aspart compared to human insulin.
Lipodystrophy:
Lipodystrophy (including lipohypertrophy, lipoatrophy) may occur at the injection site. Continuous
rotation of the injection site within the particular injection area reduces the risk of developing these
reactions.
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Based on post-marketing sources and clinical trials, the frequency, type and severity of adverse
reactions observed in the paediatric population do not indicate any differences to the broader
experience in the general population.
Other special populations
Based on post-marketing sources and clinical trials, the frequency, type and severity of adverse
reactions observed in the elderly patients and in patients with renal or hepatic impairment do not
indicate any differences to the broader experience in the general population.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare
professionals are asked to report any suspected adverse reactions via the national reporting system
listed in Appendix V.
4.9 Overdose
A specific overdose for insulin cannot be defined, however, hypoglycaemia may develop over
sequential stages if too high doses relative to the patients requirement are administered:
Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary

products. It is therefore recommended that the diabetic patient always carries sugarcontaining
products.
Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated with
glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person, or with
glucose given intravenously by physicians or other healthcare staff. Glucose must be given
intravenously, if the patient does not respond to glucagon within 10 to 15 minutes. Upon
regaining consciousness, administration of oral carbohydrates is recommended for the patient in
order to prevent a relapse.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Drugs used in diabetes. Insulins and analogues for injection, fast-acting.
ATC code: A10AB05.
Mechanism of action and pharmacodynamic effects
The blood glucose lowering effect of insulin aspart is due to the facilitated uptake of glucose following
binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose
output from the liver.
NovoRapid produces a more rapid onset of action compared to soluble human insulin, together with a
lower glucose concentration, as assessed within the first four hours after a meal. NovoRapid has a
shorter duration of action compared to soluble human insulin after subcutaneous injection.
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Fig. I. Blood glucose concentrations following a single pre-meal dose of NovoRapid injected
immediately before a meal (solid curve) or soluble human insulin administered 30 minutes before a
meal (hatched curve) in patients with type 1 diabetes mellitus.
When NovoRapid is injected subcutaneously, the onset of action will occur within 10 to 20 minutes of
injection. The maximum effect is exerted between 1 and 3 hours after injection. The duration of action
is 3 to 5 hours.
Clinical efficacy
Clinical trials in patients with type 1 diabetes have demonstrated a lower postprandial blood glucose
with NovoRapid compared to soluble human insulin (Fig. I). In two long-term open label trials in
patients with type 1 diabetes comprising 1070 and 884 patients, respectively, NovoRapid reduced
glycated haemoglobin by 0.12 [95% C.I. 0.03; 0.22] percentage points and by 0.15 [95% C.I. 0.05;
0.26] percentage points compared to human insulin; a difference of limited clinical significance.
Clinical trials in patients with type 1 diabetes have demonstrated a reduced risk of nocturnal
hypoglycaemia with insulin aspart compared with soluble human insulin. The risk of daytime
hypoglycaemia was not significantly increased.
Insulin aspart is equipotent to soluble human insulin on a molar basis.
Special populations

A randomised, double-blind cross-over PK/PD trial comparing insulin aspart with soluble human
insulin was performed in elderly patients with type 2 diabetes (19 patients aged 65-83 years, mean age
70 years). The relative differences in the pharmacodynamic properties (GIRmax,AUCGIR, 0-120 min)
between insulin aspart and human insulin in the elderly were similar to those seen in healthy subjects
and in younger patients with diabetes.
A clinical trial comparing preprandial soluble human insulin with postprandial insulin aspart was
performed in small children (20 patients aged 2 to less than 6 years, studied for 12 weeks, among those
four were younger than 4 years old) and a single dose PK/PD trial was performed in children (6-
12 years) and adolescents (13-17 years). The pharmacodynamic profile of insulin aspart in children
was similar to that seen in adults.
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The efficacy and safety of NovoRapid given as bolus insulin in combination with either insulin
detemir or insulin degludec as basal insulin has been studied for up to 12 months, in two randomised
controlled clinical trials in adolescents and children aged 1 to less than 18 years (n=712). The trials
included 167 children aged 1-5 years, 260 aged 6-11 and 285 aged 12-17. The observed improvements
in HbA1c and the safety profiles were comparable between all age groups.
Pregnancy
A clinical trial comparing safety and efficacy of insulin aspart vs. human insulin in the treatment of
pregnant women with type 1 diabetes (322 exposed pregnancies (insulin aspart: 157; human insulin:
165)) did not indicate any adverse effect of insulin aspart on pregnancy or on the health of the
foetus/newborn.
In addition the data from a clinical trial including 27 women with gestational diabetes randomised to
treatment with insulin aspart vs. human insulin (insulin aspart: 14; human insulin: 13) showed similar
safety profiles between treatments.
5.2 Pharmacokinetic properties
Absorption, distribution and elimination
In NovoRapid substitution of amino acid proline with aspartic acid at position B28 reduces the
tendency to form hexamers as observed with soluble human insulin. NovoRapid is therefore more
rapidly absorbed from the subcutaneous layer compared to soluble human insulin.
The time to maximum concentration is, on average, half of that for soluble human insulin. A mean
maximum plasma concentration of 492256 pmol/l was reached 40 (interquartile range: 3040)
minutes after a subcutaneous dose of 0.15 unit/kg bodyweight in type 1 diabetic patients. The insulin
concentrations returned to baseline about 4 to 6 hours after dose. The absorption rate was somewhat
slower in type 2 diabetic patients, resulting in a lower Cmax (352240 pmol/l) and later tmax (60
(interquartile range: 5090) minutes). The intra-individual variability in time to maximum
concentration is significantly less for NovoRapid than for soluble human insulin, whereas the intra-
individual variability in Cmax for NovoRapid is larger.
Special populations

The relative differences in pharmacokinetic properties between insulin aspart and soluble human
insulin in elderly patients (65-83 years, mean age 70 years) with type 2 diabetes were similar to those
observed in healthy subjects and in younger patients with diabetes. A decreased absorption rate was
observed in elderly patients, resulting in a later tmax (82 (interquartile range: 60-120) minutes), whereas
Cmax was similar to that observed in younger patients with type 2 diabetes and slightly lower than in
patients with type 1 diabetes.
Hepatic impairment
A single dose pharmacokinetic study of insulin aspart was performed in 24 subjects with hepatic
function ranging from normal to severely impaired. In patients with hepatic impairment, absorption
rate was decreased and more variable, resulting in delayed tmax from about 50 min in subjects with
normal hepatic function to about 85 min in patients with moderate and severe hepatic impairment.
AUC, Cmax and CL/F were similar in patients with reduced hepatic function compared with subjects
with normal hepatic function.
Renal impairment
A single dose pharmacokinetic study of insulin aspart in 18 subjects with renal function ranging from
normal to severely impaired was performed. No apparent effect of creatinine clearance values on
AUC, Cmax, CL/F and tmax of insulin aspart was found. Data were limited in patients with moderate and
severe renal impairment. Patients with renal failure necessitating dialysis treatment were not
investigated.
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The pharmacokinetic and pharmacodynamic properties of NovoRapid were investigated in children
(612 years) and adolescents (1317 years) with type 1 diabetes. Insulin aspart was rapidly absorbed
in both age groups, with similar tmax as in adults. However, Cmax differed between the age groups,
stressing the importance of the individual titration of NovoRapid.
5.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety
pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction and development.
In in vitro tests, including binding to insulin and IGF-1 receptor sites and effects on cell growth,
insulin aspart behaved in a manner that closely resembled human insulin. Studies also demonstrate that
the dissociation of binding to the insulin receptor of insulin aspart is equivalent to human insulin.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Glycerol
Phenol
Metacresol
Zinc chloride
Disodium phosphate dihydrate
Sodium chloride
Hydrochloric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)
Water for injections
6.2 Incompatibilities
Substances added to NovoRapid may cause degradation of insulin aspart.

This medicinal product must not be diluted or mixed with other medicinal products, except infusion
fluids as described in section 4.2.
6.3 Shelf life
Before opening: 30 months.
NovoRapid vial/NovoRapid Penfill/NovoRapid FlexPen/NovoRapid InnoLet/NovoRapid FlexTouch

During use or when carried as a spare: The product must be stored for a maximum of 4 weeks. Store
below 30C.
NovoRapid PumpCart
During use or when carried as a spare: NovoRapid PumpCart carried as a spare can be kept for up to
2 weeks below 30C. Thereafter it can be used for up to 7 days below 37C in an insulin infusion
pump system designed to be used with this cartridge, such as the Accu-Chek Insight and YpsoPump
insulin pumps.
6.4 Special precautions for storage
For storage conditions of the medicinal product, see section 6.3.
Before opening: Store in a refrigerator (2C - 8C). Do not freeze.
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NovoRapid vial/NovoRapid Penfill
During use or when carried as a spare: Store below 30C. Do not refrigerate. Do not freeze.
Keep the vial/cartridge in the outer carton in order to protect from light.
NovoRapid FlexPen/NovoRapid InnoLet/NovoRapid FlexTouch

During use or when carried as a spare: Store below 30C. Do not refrigerate. Do not freeze.
Keep the pen cap on the pen in order to protect from light.
NovoRapid PumpCart
During use or when carried as a spare: Store below 37C (in use) or store below 30C (carried as a
spare). Do not refrigerate. Do not freeze.
Keep the cartridge in the outer carton in order to protect from light.
6.5 Nature and contents of container
NovoRapid vial
10 ml solution in vial (type 1 glass) closed with a disc (bromobutyl/polyisoprene rubber) and a
protective tamper-proof plastic cap.
Pack sizes of 1 or 5 vials of 10 ml or a multipack containing 5 packs of 1 x 10 ml vials. Not all pack
sizes may be marketed.
NovoRapid Penfill
3 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure
(bromobutyl/polyisoprene).
Pack sizes of 5 and 10 cartridges. Not all pack sizes may be marketed.
NovoRapid FlexPen
(bromobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene.
Pack sizes of 1 (with or without needles), 5 (without needles) and 10 (without needles) pre-filled pens.
Not all pack sizes may be marketed.
NovoRapid InnoLet
Pack sizes of 1, 5 and 10 pre-filled pens. Not all pack sizes may be marketed.
NovoRapid FlexTouch
Pack sizes of 1 (with or without needles), 5 (without needles) or a multipack with 2 x 5 (without
needles) pre-filled pens of 3 ml. Not all pack sizes may be marketed.
NovoRapid PumpCart
1.6 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure
(bromobutyl/polyisoprene).
Pack size of 5 cartridges and a multipack containing 25 (5 packs of 5) cartridges. Not all pack sizes
may be marketed.
6.6 Special precautions for disposal and other handling
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Do not use this medicinal product if you notice that the solution is not clear, colourless and aqueous.
NovoRapid which has been frozen must not be used.
The patient should be advised to discard the needle after each injection.
NovoRapid may be used in an infusion pump system (CSII) as described in section 4.2. Tubings in
which the inner surface materials are made of polyethylene or polyolefin have been evaluated and
found compatible with pump use.
Any unused medicinal product or waste material should be disposed of in accordance with local
requirements.
Needles, syringes, cartridges, pre-filled pens and infusion sets must not be shared.
The cartridge must not be refilled.
In case of emergency in current NovoRapid users (hospitalisation or insulin pen malfunction),

NovoRapid can be withdrawn with an U100 insulin syringe from a NovoRapid cartridge or pre-filled
pen.
NovoRapid PumpCart
NovoRapid PumpCart is a pre-filled cartridge ready for use directly in the pump. Please refer to the
package leaflet where detailed instructions for use are provided.
To ensure correct dosing, NovoRapid PumpCart must not be used in an insulin pen.
this cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps, as described in section
4.2. Tubings in which the inner surface materials are made of polyethylene or polyolefin have been
evaluated and found compatible with pump use.
7. MARKETING AUTHORISATION HOLDER
Novo Nordisk A/S, Novo All, DK-2880 Bagsvrd, Denmark
8. MARKETING AUTHORISATION NUMBERS
NovoRapid vial
EU/1/99/119/001
EU/1/99/119/008
EU/1/99/119/015
NovoRapid Penfill
EU/1/99/119/003
EU/1/99/119/006
NovoRapid FlexPen
EU/1/99/119/009
EU/1/99/119/010
EU/1/99/119/011
EU/1/99/119/017
EU/1/99/119/018
NovoRapid InnoLet
EU/1/99/119/012
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EU/1/99/119/013
EU/1/99/119/014
NovoRapid FlexTouch
EU/1/99/119/019
EU/1/99/119/020
EU/1/99/119/021
EU/1/99/119/022
EU/1/99/119/023
NovoRapid PumpCart
EU/1/99/119/024
EU/1/99/119/025
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 7 September 1999

Date of last renewal: 30 April 2009
10. DATE OF REVISION OF THE TEXT
Detailed information on this medicinal product is available on the website of the European Medicines
Agency http://www.ema.europa.eu.
15
ANNEX II
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE

SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR
BATCH RELEASE
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY

AND USE
C. OTHER CONDITIONS AND REQUIREMENTS OF THE

MARKETING AUTHORISATION
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE

SAFE AND EFFECTIVE USE OF THE MEDICINAL
PRODUCT
16
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturers of the biological active substance
Novo Nordisk A/S

Hallas All
DK-4400 Kalundborg
Denmark
Novo Nordisk A/S

Novo All
DK-2880 Bagsvrd
Denmark
Name and address of the manufacturers responsible for batch release
NovoRapid Vial, InnoLet, FlexTouch and PumpCart:
Novo Nordisk A/S

Novo All
DK-2880 Bagsvrd
Denmark
NovoRapid Penfill and FlexPen:
Novo Nordisk A/S

Novo All
DK-2880 Bagsvrd
Denmark
Novo Nordisk Production SAS

45, Avenue dOrlans
F-28000 Chartres
France
The printed package leaflet of the medicinal product must state the name and address of the
manufacturer responsible for the release of the concerned batch.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Medicinal product subject to medical prescription.
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING

AUTHORISATION
Periodic Safety Update Reports
The requirements for submission of periodic safety update reports for this medicinal product are set
out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive
2001/83/EC and any subsequent updates published on the European medicines webportal.
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND

EFFECTIVE USE OF THE MEDICINAL PRODUCT
17
Risk Management Plan (RMP)
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the
agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent
updates of the RMP.
An updated RMP should be submitted:

At the request of the European Medicines Agency;
Whenever the risk management system is modified, especially as the result of new information
being received that may lead to a significant change to the benefit/risk profile or as the result of
an important (pharmacovigilance or risk minimisation) milestone being reached.
18
ANNEX III
LABELLING AND PACKAGE LEAFLET
19
A. LABELLING
20
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OUTER CARTON (VIAL)
NovoRapid 100 units/ml solution for injection

Insulin aspart
2. STATEMENT OF ACTIVE SUBSTANCE
1 ml solution contains 100 units insulin aspart (equivalent to 3.5 mg). 1 vial contains 10 ml equivalent
to 1,000 units,
3. LIST OF EXCIPIENTS
glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride,
hydrochloric acid/sodium hydroxide for pH adjustment and water for injections.
4. PHARMACEUTICAL FORM AND CONTENTS
1 vial of 10 ml
5 vials of 10 ml
Multipack: 5 packs of 1 x 10 ml vials.
5. METHOD AND ROUTES OF ADMINISTRATION
Read the package leaflet before use

Subcutaneous or intravenous use
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

OF THE SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children
7. OTHER SPECIAL WARNING, IF NECESSARY
Use only clear and colourless solution
8. EXPIRY DATE
EXP/
During use: Use within 4 weeks
21
9. SPECIAL STORAGE CONDITIONS
Before opening: Store in a refrigerator (2C to 8C)

During use: Do not refrigerate. Store below 30C
Do not freeze
Keep the vial in the outer carton in order to protect from light
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
Discard the needle after each injection
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Novo Nordisk A/S

Novo All
DK-2880 Bagsvrd
Denmark
EU/1/99/119/001 1 vial of 10 ml
EU/1/99/119/008 5 vials of 10 ml
EU/1/99/119/015 Multipack: 5 packs of 1 x 10 ml vials
13. BATCH NUMBER
Batch:
14. GENERAL CLASSIFICATION FOR SUPPLY
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
NovoRapid
17. UNIQUE IDENTIFIER 2D BARCODE
2D barcode carrying the unique identifier included
18. UNIQUE IDENTIFIER HUMAN READABLE DATA
PC:
SN:
NN:
22
OUTER WRAPPER LABEL ON MULTIPACKS (VIAL)

Insulin aspart
1 ml solution contains 100 units insulin aspart (equivalent to 3.5 mg). 1 vial contains 10 ml equivalent
to 1,000 units,
1 x 10 ml vials. This is a multipack of 5 vials and not for sale as individual vials


7. OTHER SPECIAL WARNING, IF NECESSARY
8. EXPIRY DATE
EXP/
23
Do not freeze
Keep the vial in the outer carton in order to protect from light

APPROPRIATE
Novo Nordisk A/S

Novo All
DK-2880 Bagsvrd
Denmark
12. MARKETING AUTHORISATION NUMBER
EU/1/99/119/015
13. BATCH NUMBER
Batch:
Medicinal product subject to medical prescription
24
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
LABEL (VIAL)
1. NAME OF THE MEDICINAL PRODUCT AND ROUTES OF ADMINISTRATION

Insulin aspart
SC, IV use
2. METHOD OF ADMINISTRATION
3. EXPIRY DATE
EXP
4. BATCH NUMBER
Batch
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
10 ml
1 vial of 10 ml contains 1,000 units
6. OTHER
Novo Nordisk A/S
25
OUTER CARTON (CARTRIDGE. Penfill)

Insulin aspart
1 ml solution contains 100 units insulin aspart (equivalent to 3.5 mg). 1 cartridge of 3 ml contains
300 units,

5 x 3 ml cartridges
10 x 3 ml cartridges


7. OTHER SPECIAL WARNINGS, IF NECESSARY

For use by one person only
8. EXPIRY DATE
EXP/
26
Do not freeze
Keep the cartridge in the outer carton in order to protect from light

APPROPRIATE
Novo Nordisk A/S

Novo All
DK-2880 Bagsvrd
Denmark
EU/1/99/119/003 5 cartridges of 3 ml
EU/1/99/119/006 10 cartridges of 3 ml
13. BATCH NUMBER
Batch:
NovoRapid Penfill
PC:
SN:
NN:
27
LABEL (CARTRIDGE. Penfill)
NovoRapid Penfill 100 units/ml solution for injection

Insulin aspart
SC, IV use
Penfill
3. EXPIRY DATE
EXP
4. BATCH NUMBER
Batch
3 ml
6. OTHER
Novo Nordisk A/S
28
OUTER CARTON (PRE-FILLED PEN. FlexPen)
NovoRapid FlexPen 100 units/ml solution for injection in pre-filled pen

Insulin aspart
1 ml solution contains 100 units insulin aspart (equivalent to 3.5 mg). 1 pre-filled pen contains 3 ml
equivalent to 300 units,
1 x 3 ml pre-filled pen
5 x 3 ml pre-filled pens
1 x 3 ml pre-filled pen + 7 NovoFine needles
1 x 3 ml pre-filled pen + 7 NovoTwist needles
Needles are not included



Designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm
8. EXPIRY DATE
29
EXP/

Do not freeze
Keep the pen cap on in order to protect from light

APPROPRIATE
Novo Nordisk A/S

Novo All
DK-2880 Bagsvrd
Denmark
EU/1/99/119/011 1 pen of 3 ml
EU/1/99/119/009 5 pens of 3 ml
EU/1/99/119/010 10 pens of 3 ml
EU/1/99/119/017 1 pen of 3 ml and 7 NovoFine needles
EU/1/99/119/018 1 pen of 3 ml and 7 NovoTwist needles
13. BATCH NUMBER
Batch:
NovoRapid FlexPen
30
PC:
SN:
NN:
31
PEN LABEL (PRE-FILLED PEN. FlexPen)
NovoRapid FlexPen 100 units/ml solution for injection

Insulin aspart
SC, IV use
FlexPen
3. EXPIRY DATE
EXP
4. BATCH NUMBER
Batch
3 ml
6. OTHER
Novo Nordisk A/S
32
OUTER CARTON (PRE-FILLED PEN. InnoLet)
NovoRapid InnoLet 100 units/ml solution for injection in pre-filled pen

Insulin aspart



33
8. EXPIRY DATE
EXP/

Do not freeze

APPROPRIATE
Novo Nordisk A/S

Novo All
DK-2880 Bagsvrd
Denmark
EU/1/99/119/012 1 pen of 3 ml
EU/1/99/119/013 5 pens of 3 ml
EU/1/99/119/014 10 pens of 3 ml
13. BATCH NUMBER
Batch:
NovoRapid InnoLet
34
PC:
SN:
NN:
35
PEN LABEL (PRE-FILLED PEN. InnoLet)
NovoRapid InnoLet 100 units/ml solution for injection

Insulin aspart
SC, IV use
InnoLet
3. EXPIRY DATE
EXP
4. BATCH NUMBER
Batch
3 ml
6. OTHER
Novo Nordisk A/S
36
OUTER CARTON (PRE-FILLED PEN. FlexTouch)

Insulin aspart
2 x (5 x 3 ml) pre-filled pens
1 x 3 ml pre-filled pen + 7 NovoFine needles
1 x 3 ml pre-filled pen + 7 NovoTwist needles



8. EXPIRY DATE
37
EXP/

Do not freeze

APPROPRIATE
Novo Nordisk A/S

Novo All
DK-2880 Bagsvrd
Denmark
EU/1/99/119/019 1 pen of 3 ml
EU/1/99/119/020 5 pens of 3 ml
EU/1/99/119/021 5 pens of 3 ml. This is part of a multipack of 10 pens and not for sale as individual
pens
EU/1/99/119/022 1 pen of 3 ml and 7 NovoFine needles
EU/1/99/119/023 1 pen of 3 ml and 7 NovoTwist needles
13. BATCH NUMBER
Batch:
NovoRapid FlexTouch
38
PC:
SN:
NN:
39
OUTER WRAPPER LABEL ON MULTIPACKS (PREFILLED PEN. FlexTouch)

Insulin aspart
2 x (5 x 3 ml). This is a multipack of 10 pre-filled pens and not for sale as individual pre-filled pens



8. EXPIRY DATE
EXP/
40

Do not freeze

APPROPRIATE
Novo Nordisk A/S

Novo All
DK-2880 Bagsvrd
Denmark
EU/1/99/119/021
13. BATCH NUMBER
Batch:
41
PEN LABEL (PRE-FILLED PEN. FlexTouch)
NovoRapid FlexTouch 100 units/ml solution for injection

Insulin aspart
SC, IV use
FlexTouch
3. EXPIRY DATE
EXP
4. BATCH NUMBER
Batch
3 ml
6. OTHER
Novo Nordisk A/S
42
OUTER CARTON (CARTRIDGE. PumpCart)

Insulin aspart
1 ml solution contains 100 units insulin aspart (equivalent to 3.5 mg). 1 cartridge contains 1.6 ml
hydrochloric acid/sodium hydroxide for pH adjustment and water for injections
Solution for injection
5 x 1.6 ml cartridges



Only for use in pumps designed for NovoRapid PumpCart
8. EXPIRY DATE
EXP/
During use in pump: Use within 7 days
43

Carried as a spare: Can be kept for up to two weeks below 30C
Do not freeze

APPROPRIATE
Novo Nordisk A/S

Novo All
DK-2880 Bagsvrd
Denmark
EU/1/99/119/024 5 cartridges of 1.6 ml
13. BATCH NUMBER
Batch:
NovoRapid PumpCart
PC:
SN:
NN:
44
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE
PACKAGING UNITS
LABEL (CARTRIDGE. PumpCart)
NovoRapid PumpCart 100 units/ml solution for injection

Insulin aspart
SC, IV use
3. EXPIRY DATE
EXP
4. BATCH NUMBER
Batch
1.6 ml
6. OTHER
Novo Nordisk A/S
45
CARTON FOR MULTIPACK (CARTRIDGE. PumpCart with blue box)

Insulin aspart
Multipack: 25 (5 packs of 5) cartridges



8. EXPIRY DATE
EXP/
46

Do not freeze

APPROPRIATE
Novo Nordisk A/S

Novo All
DK-2880 Bagsvrd
Denmark
EU/1/99/119/025 25 (5 packs of 5) cartridges
13. BATCH NUMBER
Batch:
NovoRapid PumpCart
PC:
SN:
NN:
47
PARTICULARS TO APPEAR ON THE INNER PACKAGING
CARTON FOR MULTIPACK (CARTRIDGE. PumpCart without blue box)

Insulin aspart
5 x 1.6 ml cartridges. Component of a multipack, cant be sold separately.



8. EXPIRY DATE
EXP/
48

Do not freeze

APPROPRIATE
Novo Nordisk A/S

Novo All
DK-2880 Bagsvrd
Denmark
EU/1/99/119/025 25 (5 packs of 5) cartridges
13. BATCH NUMBER
Batch:
NovoRapid PumpCart
PC:
SN:
NN:
49
B. PACKAGE LEAFLET
50
Package leaflet: Information for the user
NovoRapid 100 units/ml solution for injection in vial

Insulin aspart
Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.
Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, nurse or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
If you get any side effects, talk with your doctor, nurse or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What NovoRapid is and what it is used for

2. What you need to know before you use NovoRapid
3. How to use NovoRapid
4. Possible side effects
5. How to store NovoRapid
6. Contents of the pack and other information
NovoRapid is a modern insulin (insulin analogue) with a rapidacting effect. Modern insulin products
are improved versions of human insulin.
NovoRapid is used to reduce the high blood sugar level in adults, adolescents and children aged 1 year
and above with diabetes mellitus (diabetes). Diabetes is a disease where your body does not produce
enough insulin to control the level of your blood sugar. Treatment with NovoRapid helps to prevent
complications from your diabetes.
NovoRapid will start to lower your blood sugar 1020 minutes after you inject it, a maximum effect
occurs between 1 and 3 hours after the injection and the effect lasts for 35 hours. Due to this short
action NovoRapid should normally be taken in combination with intermediateacting or longacting
insulin preparations. Moreover NovoRapid can be used for continuous infusion in a pump system.
Do not use NovoRapid
If you are allergic to insulin aspart, or any of the other ingredients in this medicine (see section
6, Contents of the pack and other information).
If you suspect hypoglycaemia (low blood sugar) is starting (see a) Summary of serious and very
common side effects in section 4).
If the protective cap is loose or missing. Each vial has a protective, tamperproof plastic cap. If
it is not in perfect condition when you get the vial, return the vial to your supplier.
If it has not been stored correctly or been frozen (see section 5, How to store NovoRapid).
If the insulin does not appear clear and colourless.
If any of these applies, do not use NovoRapid. Talk with your doctor, nurse
or pharmacist for advice.
51
Before using NovoRapid
Check the label to make sure it is the right type of insulin.

Remove the protective cap.
Always use a new needle for each injection to prevent contamination.
Needles and syringes must not be shared.
Warnings and precautions
Some conditions and activities can affect your need for insulin. Consult your doctor:
If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands.
If you exercise more than usual or if you want to change your usual diet, as this may affect your
blood sugar level.
If you are ill, carry on taking your insulin and consult your doctor.
If you are going abroad, travelling over time zones may affect your insulin needs and the timing
of your injections.
Children and adolescents
Do not give this medicine to children below 1 year of age since no clinical studies have been carried
out in children below the age of 1 year.
Other medicines and NovoRapid
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other
medicines.
Some medicines affect your blood sugar level and this may mean that your insulin dose has to change.
Listed below are the most common medicines which may affect your insulin treatment.
Your blood sugar level may fall (hypoglycaemia) if you take:

Other medicines for the treatment of diabetes
Monoamine oxidase inhibitors (MAOI) (used to treat depression)
Betablockers (used to treat high blood pressure)
Angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high
blood pressure)
Salicylates (used to relieve pain and lower fever)
Anabolic steroids (such as testosterone)
Sulphonamides (used to treat infections).
Your blood sugar level may rise (hyperglycaemia) if you take:

Oral contraceptives (birth control pills)
Thiazides (used to treat high blood pressure or excessive fluid retention)
Glucocorticoids (such as cortisone used to treat inflammation)
Thyroid hormones (used to treat thyroid gland disorders)
Sympathomimetics (such as epinephrine [adrenaline], or salbutamol, terbutaline used to treat
asthma)
Growth hormone (medicine for stimulation of skeletal and somatic growth and pronounced
influence on the bodys metabolic processes)
Danazol (medicine acting on ovulation).
Octreotide and lanreotide (used for treatment of acromegaly, a rare hormonal disorder that usually
occurs in middleaged adults, caused by the pituitary gland producing excess growth hormone) may
either increase or decrease your blood sugar level.
Betablockers (used to treat high blood pressure) may weaken or suppress entirely the first warning
symptoms which help you to recognise low blood sugar.
52
Pioglitazone (tablets used for the treatment of type 2 diabetes)
Some patients with longstanding type 2 diabetes and heart disease or previous stroke who were
treated with pioglitazone and insulin experienced the development of heart failure. Inform your doctor
as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid
increase in weight or localised swelling (oedema).
If you have taken any of the medicines listed here, tell your doctor, nurse or pharmacist.
Drinking alcohol and taking NovoRapid
If you drink alcohol, your need for insulin may change as your blood sugar level may either rise
or fall. Careful monitoring is recommended.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor
for advice before taking this medicine. NovoRapid can be used during pregnancy. Your insulin
dose may need to be changed during pregnancy and after delivery. Careful control of your
diabetes, particularly prevention of hypoglycaemia, is important for the health of your baby.
There are no restrictions on treatment with NovoRapid during breastfeeding.
Ask your doctor, nurse or pharmacist for advice before taking this medicine while pregnant or breast
feeding.
Driving and using machines
Please ask your doctor whether you can drive a car or operate a machine:
If you have frequent hypoglycaemia.
If you find it hard to recognise hypoglycaemia.
If your blood sugar is low or high, your concentration and ability to react might be affected and
therefore also your ability to drive or operate a machine. Bear in mind that you could endanger
yourself or others.
NovoRapid has a rapid onset of effect therefore if hypoglycaemia occurs, you may experience it earlier
after an injection when compared to soluble human insulin.
Important information about some of the ingredients of NovoRapid
NovoRapid contains less than 1 mmol sodium (23 mg) per dose, i.e. NovoRapid is essentially
sodiumfree.
Dose and when to take your insulin
Always use your insulin and adjust your dose exactly as your doctor has told you. Check with your
doctor, nurse or pharmacist if you are not sure.
NovoRapid is generally taken immediately before a meal. Eat a meal or snack within 10 minutes of the
injection to avoid low blood sugar. When necessary, NovoRapid can be given soon after a meal. See
How and where to inject below for information.
Do not change your insulin unless your doctor tells you to. If your doctor has switched you from one
type or brand of insulin to another, your dose may have to be adjusted by your doctor.
53
Use in children and adolescents
NovoRapid can be used in adolescents and children aged 1 year and above instead of soluble human
insulin when a rapid onset of effect is preferred. For example, when it is difficult to dose the child in
relation to meals.
Use in special patient groups
If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check
your blood sugar more regularly and discuss changes in your insulin dose with your doctor.
How and where to inject
NovoRapid is for injection under the skin (subcutaneously) or for continuous infusion in a pump
system. Administration in a pump system will require a comprehensive instruction by your healthcare
professional. You must never inject yourself directly into a vein (intravenously) or muscle
(intramuscularly). If necessary NovoRapid can be given directly into a vein but this must only be done
by physicians or other healthcare staff.
With each injection, change the injection site within the particular area of skin that you use. This may
reduce the risk of developing lumps or skin pitting (see section 4, Possible side effects). The best
places to give yourself an injection are: the front of your waist (abdomen), the upper arm or the front
of your thighs. The insulin will work more quickly if you inject into the waist (abdomen). You should
always measure your blood sugar regularly.
How to take NovoRapid
If you use only one type of insulin

1. Draw into the syringe the same amount of air as the dose of insulin you are going to inject.
Inject the air into the vial.
2. Turn the vial and syringe upside down and draw the correct insulin dose into the syringe. Pull
the needle out of the vial. Then expel the air from the syringe and check that the dose is correct.
If you have to mix two types of insulin

1. Just before use, roll the longacting (cloudy) insulin between your hands until the liquid is
uniformly white and cloudy.
2. Draw into the syringe the same amount of air as the dose of longacting insulin. Inject the air
into the vial containing longacting insulin and pull out the needle.
3. Draw into the syringe the same amount of air as the dose of NovoRapid. Inject the air into the
vial containing NovoRapid. Turn the vial and syringe upside down and draw up the prescribed
dose of NovoRapid. Expel any air from the syringe and check that the dose is correct.
4. Push the needle into the vial of longacting insulin, turn the vial and syringe upside down and
draw out the dose you have been prescribed. Expel any air from the syringe and check the dose.
Inject the mixture immediately.
5. Always mix NovoRapid and longacting insulin in the same sequence.
How to inject NovoRapid
Inject the insulin under the skin. Use the injection technique advised by your doctor or nurse.
Keep the needle under your skin for at least 6 seconds to make sure you have injected all the
insulin.
Discard the needle after each injection.
For use in an infusion pump system
NovoRapid should never be mixed with any other insulin when used in a pump.
54
Follow the instructions and recommendations from your doctor regarding the use of NovoRapid in a
pump. Before use of NovoRapid in the pump system, you must have received a comprehensive
instruction in the use and information about any actions to be taken in case of illness, too high or too
low blood sugar or failure of the pump system.
Before inserting the needle, use soap and water to clean your hands and the skin where the
needle is inserted to avoid any infection at the infusion site.
When you fill a new reservoir, be certain not to leave large air bubbles in either the syringe or
the tubing.
Changing of the infusion set (tubing and needle) must be done according to the instructions in
the product information supplied with the infusion set.
To get the benefit of insulin infusion, and to detect possible malfunction of the insulin pump, it is
recommended that you measure your blood sugar level regularly.
What to do in case of pump system failure
You should always have an alternative delivery method for your insulin available for injection under
the skin in case of pump system failure.
If you take more insulin than you should
If you take too much insulin your blood sugar gets too low (hypoglycaemia). See a) Summary of
serious and very common side effects in section 4.
If you forget to take your insulin
If you forget to take your insulin your blood sugar may get too high (hyperglycaemia). See c) Effects
from diabetes in section 4.
If you stop taking your insulin
Do not stop taking your insulin without speaking with a doctor, who will tell you what needs to be
done. This could lead to very high blood sugar (severe hyperglycaemia) and ketoacidosis. See c)
Effects from diabetes in section 4.
If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
a) Summary of serious and very common side effects
Low blood sugar (hypoglycaemia) is a very common side effect. It may affect more than 1 in 10
people.
Low blood sugar may occur if you:

Inject too much insulin.
Eat too little or miss a meal.
Exercise more than usual.
Drink alcohol (see Drinking alcohol and taking NovoRapid in section 2).
Signs of low blood sugar: Cold sweat; cool pale skin; headache; rapid heartbeat; feeling sick; feeling
very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness
or tremor; feeling anxious; feeling confused; difficulty in concentrating.
55
Severe low blood sugar can lead to unconsciousness. If prolonged severe low blood sugar is not
treated, it can cause brain damage (temporary or permanent) and even death. You may recover more
quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how
to use it. If you are given glucagon you will need glucose or a sugar snack as soon as you are
conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital.
What to do if you experience low blood sugar:

If you experience low blood sugar, eat glucose tablets or another high sugar snack (e.g. sweets,
biscuits, fruit juice). Measure your blood sugar if possible and rest. Always carry glucose tablets
or high sugar snacks with you, just in case.
When symptoms of low blood sugar have disappeared or when blood sugar level is stabilised,
continue insulin treatment as usual.
If you have such a low blood sugar that it makes you pass out, if you have had need for injection
of glucagon, or if you have experienced many incidents of low blood sugar, talk with a doctor.
The amount or timing of insulin, food or exercise may need to be adjusted.
Tell relevant people that you have diabetes and what the consequences may be, including the risk of
passing out (become unconscious) due to low blood sugar. Let them know that if you pass out, they
must turn you on your side and get medical help straight away. They must not give you any food or
drink due to risk of suffocation.
Serious allergic reactions to NovoRapid or one of its ingredients (called a systemic allergic reaction)
is a very rare side effect but can potentially be life threatening. It may affect less than 1 in 10,000
people.
Seek medical advice immediately:

If signs of allergy spread to other parts of your body.
If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty
in breathing; have a rapid heartbeat; feel dizzy.
If you notice any of these signs, seek medical advice immediately.
b) List of other side effects
Uncommon side effects

May affect less than 1 in 100 people.
Signs of allergy: Local allergic reactions (pain, redness, hives, inflammation, bruising, swelling and
itching) at the injection site may occur. These usually disappear after a few weeks of taking your
insulin. If they do not disappear, or if they spread throughout your body, talk to your doctor
immediately. See also Serious allergic reactions above.
Vision problems: When you first start your insulin treatment, it may disturb your vision, but the
disturbance is usually temporary.
Changes at the injection site (lipodystrophy): The fatty tissue under the skin at the injection site may
shrink (lipoatrophy) or thicken (lipohypertrophy). Changing the site with each injection reduces the
risk of developing such skin changes. If you notice your skin pitting or thickening at the injection site,
tell your doctor or nurse. These reactions can become more severe, or they may change the absorption
of your insulin, if you inject in such a site.
Swollen joints: When you start taking insulin, water retention may cause swelling around your ankles
and other joints. Normally this soon disappears. If not, talk to your doctor.
Diabetic retinopathy (an eye disease related to diabetes which can lead to loss of vision): If you have
diabetic retinopathy and your blood sugar level improves very fast, the retinopathy may get worse.
Ask your doctor about this.
56
Rare side effects
May affect less than 1 in 1,000 people.
Painful neuropathy (pain due to nerve damage): If your blood sugar level improves very fast, you may
get nerve related pain, this is called acute painful neuropathy and is usually transient.
Reporting of side effects
If you get any side effects, talk with your doctor, nurse or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the national reporting
system listed in Appendix V. By reporting side effects you can help provide more information on the
safety of this medicine.
c) Effects from diabetes
High blood sugar (hyperglycaemia)
High blood sugar may occur if you:

Have not injected enough insulin.
Forget to inject your insulin or stop taking insulin.
Repeatedly inject less insulin than you need.
Get an infection and/or a fever.
Eat more than usual.
Exercise less than usual.
Warning signs of high blood sugar:

The warning signs appear gradually. They include: increased urination; feeling thirsty; losing your
appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed; dry skin; dry mouth and a
fruity (acetone) smell of the breath.
What to do if you experience high blood sugar:

If you get any of the above signs: test your blood sugar level, test your urine for ketones if you
can, then seek medical advice immediately.
These may be signs of a very serious condition called diabetic ketoacidosis (buildup of acid in
the blood because the body is breaking down fat instead of sugar). If you do not treat it, this
could lead to diabetic coma and eventually death.
Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the vial label and carton, after EXP.
The expiry date refers to the last day of that month.
Keep the vial in the outer carton in order to protect it from light.
Before opening: Store in a refrigerator at 2C to 8C. Do not freeze.
During use or when carried as a spare: The product may be stored for a maximum of 4 weeks. Store
below 30C. Do not refrigerate or freeze.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.
57
What NovoRapid contains
The active substance is insulin aspart. Each ml contains 100 units of insulin aspart. Each vial
contains 1,000 units of insulin aspart in 10 ml solution for injection.
The other ingredients are glycerol, phenol, metacresol, zinc chloride, disodium phosphate
dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.
What NovoRapid looks like and contents of the pack
NovoRapid is presented as a solution for injection.
Pack sizes of 1 or 5 vials of 10 ml or a multipack of 5 packs of 1 x 10 ml vials. Not all pack sizes may
be marketed.
The solution is clear and colourless.
Marketing Authorisation Holder and Manufacturer
This leaflet was last revised in
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website:
http://www.ema.europa.eu.
58

Insulin aspart


If the cartridge or the device containing the cartridge is dropped, damaged or crushed.
If any of these applies, do not use NovoRapid. Talk with your doctor, nurse or pharmacist for advice.
59
Always check the cartridge, including the rubber plunger at the bottom of the cartridge. Do not
use it if any damage is seen or if the rubber plunger has been drawn above the white label band
at the bottom of the cartridge. This could be a result of leakage of insulin. If you suspect the
cartridge is damaged, take it back to your supplier. See your pen manual for further instructions.
Needles and NovoRapid Penfill must not be shared.
blood sugar level.
of your injections.
medicines.

blood pressure)

asthma)
60
feeding.
yourself or others.
sodiumfree.
61
relation to meals.

Do not refill the cartridge. Once empty, it must be disposed of.

NovoRapid Penfill cartridges are designed to be used with Novo Nordisk insulin delivery
systems and NovoFine or NovoTwist needles.
If you are treated with NovoRapid Penfill and another insulin Penfill cartridge, you should use
two insulin delivery systems, one for each type of insulin.
Always carry a spare Penfill cartridge in case it is lost or damaged.
How to inject NovoRapid
Inject the insulin under the skin. Use the injection technique advised by your doctor or nurse
and as described in your pen manual.
Keep the needle under your skin for at least 6 seconds. Keep the pushbutton fully depressed
until the needle has been withdrawn from the skin. This will ensure correct delivery and limit
possible flow of blood into the needle or insulin reservoir.
Remove and discard the needle after each injection. Always store NovoRapid without the needle
attached. Otherwise the liquid may leak out which can cause inaccurate dosing.
62
people.


people.

63
Rare side effects




64

Do not use this medicine after the expiry date which is stated on the cartridge label and carton, after
EXP. The expiry date refers to the last day of that month.
Always keep the cartridge in the outer carton when you are not using it in order to protect it from light.
NovoRapid must be protected from excessive heat and light.
Before opening: NovoRapid Penfill that is not being used is to be stored in the refrigerator at 2C to
8C, away from the cooling element. Do not freeze.
During use or when carried as a spare: NovoRapid Penfill that is being used or carried as a spare is
not to be kept in the refrigerator. You can carry it with you and keep it at room temperature (below
30C) for up to 4 weeks.
The active substance is insulin aspart. Each ml contains 100 units of insulin aspart. Each
cartridge contains 300 units of insulin aspart in 3 ml solution for injection.
Pack sizes of 5 and 10 cartridges of 3 ml. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
The manufacturer can be identified by the batch number printed on the slip of the carton and on the
label:
If the second and third characters are S6, P5, K7, R7, VG, FG or ZF, the manufacturer is Novo
Nordisk A/S, Novo All, DK-2880 Bagsvrd, Denmark.
If the second and third characters are H7 or T6, the manufacturer is Novo Nordisk Production
SAS, 45 Avenue dOrlans F-28000 Chartres, France.
65
66
NovoRapid FlexPen 100 units/ml solution for injection in prefilled pen

Insulin aspart

If FlexPen is dropped, damaged or crushed.
67
Needles and NovoRapid FlexPen must not be shared.
blood sugar level.
of your injections.
medicines.

blood pressure)

asthma)

68
feeding.
yourself or others.
sodiumfree.
69
relation to meals.
How to handle NovoRapid FlexPen
NovoRapid FlexPen is a pre-filled, colourcoded, disposable pen containing insulin aspart.
Read carefully the instructions for use included in this package leaflet. You must use the pen as
described in the Instructions for Use.
Always ensure you use the correct pen before you inject your insulin.
70
people.


people.


71
Rare side effects





Do not use this medicine after the expiry date which is stated on the FlexPen label and carton, after
72
Always keep the pen cap on your FlexPen when you are not using it in order to protect it from light.
Before opening: NovoRapid FlexPen that is not being used is to be stored in the refrigerator at 2C to
During use or when carried as a spare: NovoRapid FlexPen that is being used or carried as a spare
is not to be kept in the refrigerator. You can carry it with you and keep it at room temperature (below
The active substance is insulin aspart. Each ml contains 100 units of insulin aspart. Each pre
filled pen contains 300 units of insulin aspart in 3 ml solution for injection.
Pack sizes of 1 (with or without needles), 5 (without needles) and 10 (without needles) prefilled pens
of 3 ml. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
The manufacturer can be identified by the batch number printed on the slip of the carton and on the
label:
If the second and third characters are S6, P5, K7, R7, VG, FG or ZF, the manufacturer is Novo
Nordisk A/S, Novo All, DK-2880 Bagsvrd, Denmark.
If the second and third characters are H7 or T6, the manufacturer is Novo Nordisk Production
SAS, 45 Avenue dOrlans F-28000 Chartres, France.
Now turn over for information on how to use your FlexPen.
73
Instructions on how to use NovoRapid solution for injection in FlexPen.
Read the following instructions carefully before using your FlexPen. If you do not follow the
instructions carefully, you may get too little or too much insulin, which can lead to too high or too low
blood sugar level.
Your FlexPen is a pre-filled dialadose insulin pen. You can select doses from 1 to 60 units in
increments of 1 unit. FlexPen is designed to be used with NovoFine or NovoTwist disposable needles
up to a length of 8 mm. As a precautionary measure, always carry a spare insulin delivery device in
case your FlexPen is lost or damaged.
NovoRapid FlexPen Dose Needle (example)

Residual scale selector Push-
Pen cap Big outer Needle
Cartridge Pointer button needle cap
Inner needle cap Paper tab
Caring for your pen

Your FlexPen must be handled with care.
If it is dropped, damaged or crushed, there is a risk of insulin leakage. This may cause inaccurate
dosing, which can lead to too high or too low blood sugar level.
You can clean the exterior of your FlexPen by wiping it with a medicinal swab. Do not soak it, wash
or lubricate it as it may damage the pen.
Do not refill your FlexPen. Once empty, it must be disposed of.
Preparing your NovoRapid FlexPen
Check the name and coloured label of your pen to make sure that it contains the correct type of
insulin. This is especially important if you take more than one type of insulin. If you take the wrong
type of insulin, your blood sugar level may get too high or too low.
A
Pull off the pen cap.
B
Remove the paper tab from a new disposable needle.
Screw the needle straight and tightly onto your FlexPen.
C
Pull off the big outer needle cap and keep it for later.
74
D
Pull off the inner needle cap and dispose of it.
Never try to put the inner needle cap back on the needle. You may stick yourself with the needle.
Always use a new needle for each injection. This reduces the risk of contamination, infection,
leakage of insulin, blocked needles and inaccurate dosing.
Be careful not to bend or damage the needle before use.
Checking the insulin flow
Prior to each injection small amounts of air may collect in the cartridge during normal use. To
avoid injection of air and ensure proper dosing:
E
Turn the dose selector to select 2 units.
2 units
selected
F
Hold your FlexPen with the needle pointing upwards and tap the cartridge gently with your finger a
few times to make any air bubbles collect at the top of the cartridge.
G
Keeping the needle upwards, press the pushbutton all the way in. The dose selector returns to 0.
A drop of insulin should appear at the needle tip. If not, change the needle and repeat the procedure no
more than 6 times.
If a drop of insulin still does not appear, the pen is defective, and you must use a new one.
75
G
Always make sure that a drop appears at the needle tip before you inject. This makes sure that
the insulin flows. If no drop appears, you will not inject any insulin, even though the dose
selector may move. This may indicate a blocked or damaged needle.
Always check the flow before you inject. If you do not check the flow, you may get too little
insulin or no insulin at all. This may lead to too high blood sugar level.
Selecting your dose
Check that the dose selector is set at 0.
H
Turn the dose selector to select the number of units you need to inject.
The dose can be corrected either up or down by turning the dose selector in either direction until the
correct dose lines up with the pointer. When turning the dose selector, be careful not to push the push
button as insulin will come out.
You cannot select a dose larger than the number of units left in the cartridge.
Always use the dose selector and the pointer to see how many units you have selected before
injecting the insulin.
Do not count the pen clicks. If you select and inject the wrong dose, your blood sugar level may
get too high or too low. Do not use the residual scale, it only shows approximately how much
insulin is left in your pen.
Making the injection
Insert the needle into your skin. Use the injection technique shown by your doctor or nurse.
I
Inject the dose by pressing the pushbutton all the way in until 0 lines up with the pointer. Be careful
only to push the pushbutton when injecting.
Turning the dose selector will not inject insulin.
76
J
Keep the pushbutton fully depressed and let the needle remain under the skin for at least 6 seconds.
This will make sure you get the full dose.
Withdraw the needle from the skin, then release the pressure on the pushbutton.
Always make sure that the dose selector returns to 0 after the injection. If the dose selector stops
before it returns to 0, the full dose has not been delivered, which may result in too high blood sugar
level.
K
Lead the needle into the big outer needle cap without touching it. When the needle is covered,
carefully push the big outer needle cap completely on and then unscrew the needle.
Dispose of it carefully and put the pen cap back on.
Always remove the needle after each injection and store your FlexPen without the needle
attached. This reduces the risk of contamination, infection, leakage of insulin, blocked needles
and inaccurate dosing.
Further important information
Caregivers must be very careful when handling used needles to reduce the risk of needle sticks
and cross-infection.
Dispose of your used FlexPen carefully without the needle attached.
Never share your pen or your needles with other people. It might lead to cross-infection.
Never share your pen with other people. Your medicine might be harmful to their health.
Always keep your pen and needles out of sight and reach of others, especially children.
77
NovoRapid InnoLet 100 units/ml solution for injection in prefilled pen

Insulin aspart

If InnoLet is dropped, damaged or crushed.
78
Needles and NovoRapid InnoLet must not be shared.
blood sugar level.
of your injections.
medicines.

blood pressure)

asthma)

79
feeding.
yourself or others.
sodiumfree.
80
relation to meals.
How to handle NovoRapid InnoLet
NovoRapid InnoLet is a pre-filled disposable pen containing insulin aspart.
81
people.


people.


82
Rare side effects





Do not use this medicine after the expiry date which is stated on the InnoLet label and carton, after
83
Always keep the pen cap on your InnoLet when you are not using it in order to protect it from light.
Before opening: NovoRapid InnoLet that is not being used is to be stored in the refrigerator at 2C to
During use or when carried as a spare: NovoRapid InnoLet that is being used or carried as a spare
is not to be kept in the refrigerator. You can carry it with you and keep it at room temperature (below
Pack sizes of 1, 5 and 10 prefilled pens of 3 ml. Not all pack sizes may be marketed.
Now turn over for information on how to use your InnoLet.
84
Instructions on how to use NovoRapid solution for injection in InnoLet
Read the instructions carefully before using your InnoLet. If you do not follow the instructions
carefully, you may get too little or too much insulin, which can lead to too high or too low blood sugar
level.
Your InnoLet is a simple, compact prefilled pen able to deliver 1 to 50 units in increments of 1 unit.
InnoLet is designed to be used with NovoFine or NovoTwist disposable needles up to a length of
8 mm. As a precautionary measure, always carry a spare insulin delivery device in case your InnoLet
is lost or damaged.
Push-button
Dose
selector
Residual
scale
Dose scale
Insulin
cartridge
Compartment
for needles
Disposable needle (example)
Needle
Pen cap Inner needle

Paper tab cap
Big outer
needle cap
Getting started
Check the name and coloured label of your InnoLet to make sure that it contains the correct type of
insulin. This is especially important if you take more than one type of insulin. If you take the wrong
type of insulin, your blood sugar level may get too high or too low.
Take off the pen cap.
Attaching the needle
Be careful not to bend or damage the needle before use.
Remove the paper tab from a new disposable needle.
Screw the needle straight and tightly onto your InnoLet (picture 1A).
Pull off the big outer needle cap and the inner needle cap. You may want to store the big
outer needle cap in the compartment.
Never try to put the inner needle cap back on the needle. You may stick yourself with the
needle.
85
Priming to expel air prior to each injection
Small amounts of air may collect in the needle and cartridge during normal use.
To avoid injection of air and ensure proper dosing:

Dial 2 units by turning the dose selector clockwise.
Hold your InnoLet with the needle upwards and tap the cartridge gently with your finger a
few times (picture 1B) to make any air bubbles collect at the top of the cartridge.
Keeping the needle upwards, press the pushbutton and the dose selector returns to 0.
Always make sure that a drop appears at the needle tip before injection (picture 1B). This
makes sure the insulin flows. If not, change the needle and repeat the procedure no more than
6 times.
If a drop of insulin still does not appear, the device is defective and must not be used.
If no drop appears, you will not inject any insulin, even though the dose selector may move.
This may indicate a blocked or damaged needle.
Always prime InnoLet before you inject. If you do not prime InnoLet, you may get too little
1B
Setting the dose
Always check that the pushbutton is fully depressed and the dose selector is set to 0.
Dial the number of units required by turning the dose selector clockwise (picture 2).
86
You will hear a click for every single unit dialled. The dose can be corrected by turning the
dial either way. Make sure not to turn the dial or correct the dose when the needle is inserted in
the skin. This may lead to inaccurate dosing that can make your blood sugar level too high or
too low.
Always use the dose scale and the dose selector to see how many units you have selected before
injecting the insulin. Do not count the pen clicks. If you select and inject the wrong dose, your
blood sugar level may get too high or too low. Do not use the residual scale, it only shows
approximately how much insulin is left in your pen.
You cannot set a dose larger than the number of units remaining in the cartridge.
Injecting the insulin
Insert the needle into your skin. Use the injection technique advised by your doctor.
Deliver the dose by pressing the pushbutton fully down (picture 3). You will hear clicks as
the dose selector returns to 0.
After the injection, the needle should remain under the skin for at least 6 seconds to ensure
that the full dose has been delivered.
Make sure not to block the dose selector while injecting, as the dose selector must be allowed
to return to 0 when you press the pushbutton. Always make sure that the dose selector returns
to 0 after the injection. If the dose selector stops before it returns to 0, the full dose has not been
delivered, which may result in too high blood sugar level.
87
3
Removing the needle
Replace the big outer needle cap and unscrew the needle (picture 4). Dispose of it carefully.
Put the pen cap back on your InnoLet to protect the insulin from light.
Always use a new needle for each injection. Always remove and discard the needle after each injection
and store your InnoLet without the needle attached. This reduces the risk of contamination, infection,
Further important information
Caregivers must be very careful when handling used needles to reduce the risk of needle sticks and
cross-infection.
Dispose of your used InnoLet carefully without the needle attached.
Always keep your InnoLet and needles out of sight and reach of others, especially children.
Caring for your pen
88
Your InnoLet is designed to work accurately and safely. It must be handled with care. If it is dropped,
damaged or crushed, there is a risk of insulin leakage. This may cause inaccurate dosing, which can
lead to too high or too low blood sugar level.
You can clean your InnoLet by wiping it with a medicinal swab. Do not soak, wash or lubricate it.
This may damage the mechanism and may cause inaccurate dosing, which can lead to too high or too
low blood sugar level.
Do not refill your InnoLet. Once empty, it must be disposed of.
89
NovoRapid FlexTouch 100 units/ml solution for injection in prefilled pen

Insulin aspart

If FlexTouch is dropped, damaged or crushed.
If any of these applies, do not use NovoRapid. Talk with your doctor, nurse
or pharmacist for advice.
90
Needles and NovoRapid FlexTouch must not be shared.
blood sugar level.
of your injections.
medicines.

blood pressure)

asthma)

91
feeding.
yourself or others.
sodiumfree.
92
relation to meals.
How to handle NovoRapid FlexTouch
NovoRapid FlexTouch is a pre-filled, colourcoded, disposable pen containing insulin aspart.
93
people.


people.


94
Rare side effects





Do not use this medicine after the expiry date which is stated on the FlexTouch label and carton, after
95
Always keep the pen cap on your FlexTouch when you are not using it in order to protect it from light.
Before opening: NovoRapid FlexTouch that is not being used is to be stored in the refrigerator at 2C
to 8C, away from the cooling element. Do not freeze.
During use or when carried as a spare: NovoRapid FlexTouch that is being used or carried as a
spare is not to be kept in the refrigerator. You can carry it with you and keep it at room temperature
(below 30C) for up to 4 weeks.
Pack sizes of 1 (with or without needles) or 5 (without needles) or a multipack with 2 x 5 (without
needles) prefilled pens of 3 ml. Not all pack sizes may be marketed.
Now turn over for information on how to use your FlexTouch.
96
Instructions on how to use NovoRapid 100 units/ml solution for injection in pre-filled pen
(FlexTouch)
Please read these instructions carefully before using your FlexTouch pre-filled pen. If you do not
follow the instructions carefully, you may get too little or too much insulin, which can lead to too high
or too low blood sugar level.
Do not use the pen without proper training from your doctor or nurse.
Start by checking your pen to make sure that it contains NovoRapid 100 units/ml, then look at the
illustrations to the right to get to know the different parts of your pen and needle.
If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use
this pen without help. Get help from a person with good eyesight who is trained to use the FlexTouch
pre-filled pen.
Your NovoRapid FlexTouch pen is a pre-filled insulin pen. NovoRapid FlexTouch contains 300 units
of insulin and delivers doses from 1 to 80 units, in increments of 1 unit.
NovoRapid FlexTouch is designed to be used with NovoFine or NovoTwist single-use disposable
needles up to a length of 8 mm.
NovoRapid FlexTouch
Pen cap Insulin Insulin Pen label Dose Dose Dose Dose
scale window counter pointer selector button
NovoRapid
FlexTouch
Needle (example)
Outer Inner Needle Paper

needle cap needle cap tab
Preparing your NovoRapid FlexTouch pen
Check the name and coloured label on your NovoRapid FlexTouch pen to make sure that it
contains the type of insulin you need. This is especially important if you take more than one type of
97
insulin. If you take a wrong type of insulin, your blood sugar level may get too high or too low.
A Pull off the pen cap.
B Check that the insulin in your pen is clear and colourless. Look through the insulin window. If
the insulin looks cloudy, do not use the pen.
C Take a new disposable needle, and tear off the paper tab.
D Screw the needle straight onto the pen. Make sure the needle is on tight.
E Pull off the outer needle cap and save it. You will need it after the injection, to correctly remove
the needle from the pen.
Pull off the inner needle cap and throw it away. If you try to put it back on, you may
accidentally stick yourself with the needle.
A drop of insulin may appear at the needle tip. This is normal.
98
E
Never use a bent or damaged needle.
Checking the insulin flow
Make sure that you receive your full dose by always checking the insulin flow before you select
and inject your dose.
F Turn the dose selector to select 2 units.
2 units
selected
G Hold the pen with the needle pointing up.
Tap the top of the pen a few times to let any air bubbles rise to the top.
H Press the dose button with your thumb until the dose counter returns to 0. The 0 must line up
with the dose pointer. A drop of insulin will appear at the needle tip.
If no drop appears, repeat steps F to H up to 6 times. If no drop appears after these new
attempts, change the needle and repeat steps F to H once more.
Do not use the pen if a drop of insulin still does not appear.
99
Always make sure that a drop appears at the needle tip before you inject. This makes sure
that the insulin flows. If no drop appears, you will not inject any insulin, even though the dose
counter may move. This may indicate a blocked or damaged needle.
Always check the flow before you inject. If you do not check the flow, you may get too little
Selecting your dose
Use the dose selector on your NovoRapid FlexTouch pen to select your dose. You can select up to
80 units per dose.
I Select the dose you need. You can turn the dose selector forwards or backwards. Stop when the
right number of units lines up with the dose pointer.
The dose selector clicks differently when turned forwards, backwards or past the number of
units left.
When the pen contains less than 80 units, the dose counter stops at the number of units left.
5 units
selected
24 units
selected
Always use the dose counter and the dose pointer to see how many units you have selected
before injecting the insulin.
Do not count the pen clicks. If you select and inject the wrong dose, your blood sugar level may
get too high or too low.
Do not use the insulin scale, it only shows approximately how much insulin is left in your pen.
How much insulin is left?

The insulin scale shows you approximately how much insulin is left in your pen.
Approx.
how much
insulin is
left
To see precisely how much insulin is left, use the dose counter:
Turn the dose selector until the dose counter stops. If it shows 80, at least 80 units are left in your
pen. If it shows less than 80, the number shown is the number of units left in your pen.
Turn the dose selector back until the dose counter shows 0.
100
If you need more insulin than the units left in your pen, you can split your dose between two pens.
Example
Dose
counter
stopped:
52 units
left
Be very careful to calculate correctly if splitting your dose.

If in doubt, take the full dose with a new pen. If you split the dose wrong, you will inject too
little or too much insulin, which can lead to too high or too low blood sugar level.
Injecting your dose
Make sure that you receive your full dose by using the right injection technique.
J Insert the needle into your skin as your doctor or nurse has shown you. Make sure you can see
the dose counter. Do not touch the dose counter with your fingers. This could interrupt the
injection.
Press the dose button until the dose counter returns to 0. The 0 must line up with the dose
pointer. You may then hear or feel a click.
After the dose counter has returned to 0, leave the needle under the skin for at least 6 seconds
to make sure that you get your full dose.
6 seconds
K Remove the needle from the skin.
After that, you may see a drop of insulin at the needle tip. This is normal and has no effect on
the dose you just received.
Always dispose of the needle after each injection. This reduces the risk of contamination,
infection, leakage of insulin, blocked needles and inaccurate dosing. If the needle is blocked,
you will not inject any insulin.
101
K
L Lead the needle tip into the outer needle cap on a flat surface. Do not touch the needle or the
cap.
Once the needle is covered, carefully push the outer needle cap completely on and then unscrew
the needle. Dispose of it carefully, and put the pen cap back on after every use.
When the pen is empty, throw it away without a needle on as instructed by your doctor, nurse or
local authorities.
Always watch the dose counter to know how many units you inject.
The dose counter will show the exact number of units. Do not count the pen clicks.
Hold the dose button down until the dose counter returns to 0 after the injection. If the dose
counter stops before it returns to 0, the full dose has not been delivered, which may result in too
high blood sugar level.
Never try to put the inner needle cap back on the needle. You may stick yourself with the
needle.
Always remove the needle after each injection and store your pen without the needle
attached. This reduces the risk of contamination, infection, leakage of insulin, blocked needles
and inaccurate dosing.
Caring for your pen
Treat your pen with care. Rough handling or misuse may cause inaccurate dosing, which can lead to
too high or too low blood sugar level.
Do not leave the pen in a car or other place where it can get too hot or too cold.
Do not expose your pen to dust, dirt or liquid.
Do not wash, soak or lubricate your pen. If necessary, clean it with mild detergent on a
moistened cloth.
Do not drop your pen or knock it against hard surfaces.

If you drop it or suspect a problem, attach a new needle and check the insulin flow before you
inject.
Do not try to refill your pen. Once empty, it must be disposed of.
102
Do not try to repair your pen or pull it apart.
Important information
Always keep your pen with you.
Always carry an extra pen and new needles with you, in case of loss or damage.
Always keep your pen and needles out of sight and reach of others, especially children.
Caregivers must be very careful when handling used needles to reduce the risk of needle
injury and cross-infection.
103

Insulin aspart

1. What NovoRapid PumpCart is and what it is used for

2. What you need to know before you use NovoRapid PumpCart
3. How to use NovoRapid PumpCart
5. How to store NovoRapid PumpCart
1. What NovoRapid PumpCart is and what it is used for
NovoRapid PumpCart is for use in a pump and covers your total daily insulin needs: both your all day
(basal) and meal-time (bolus) insulin needs. Before you use NovoRapid PumpCart in the pump you
must have received a comprehensive instruction by your doctor or nurse.
Basal (all-day) insulin requirements: When you use NovoRapid PumpCart in a pump, your insulin
will be constantly delivered to cover your basal need for insulin. If you change the basal insulin setting
the change will start to affect you within 1020 minutes. If you stop the pump, the insulin effect will
last for 3 to 5 hours. Before you set or change the basal rate, carefully read the pump manual (user
guide).
Bolus (meal-time) insulin requirements: NovoRapid will start to lower your blood sugar within
10-20 minutes after you start a bolus delivery (see section 3, How to use NovoRapid PumpCart, for
more information about how to adjust your bolus dose). The maximum effect occurs between 1 and
3 hours after the bolus delivery and the effect lasts for 3 to 5 hours.
2. What you need to know before you use NovoRapid PumpCart
Do not use NovoRapid PumpCart
104
If the cartridge or the device containing the cartridge is dropped, damaged or crushed.
If it has not been stored correctly or been frozen (see section 5, How to store NovoRapid
PumpCart).
If any of these applies, do not use NovoRapid PumpCart. Talk with your
doctor, nurse or pharmacist for advice.
Before using NovoRapid PumpCart

Always check the cartridge, including the rubber plunger at the bottom of the cartridge. Do not
use it if any damage or leakage is seen or if the rubber plunger has been drawn above the white
label band at the bottom of the cartridge. This could be a result of leakage of insulin. If you
suspect the cartridge is damaged, take it back to your supplier.
Infusion sets (tubing and needle) and NovoRapid PumpCart must not be shared.
blood sugar level.
of your injections.
Other medicines and NovoRapid PumpCart
medicines.

blood pressure)

105
asthma)

feeding.
yourself or others.
sodiumfree.
3. How to use NovoRapid PumpCart
106
Always use your insulin and adjust your basal (all-day) and bolus (meal time) doses exactly as your
doctor has told you. Check with your doctor, nurse or pharmacist if you are not sure. Your bolus
(meal-time) insulin needs to be adjusted based on your blood sugar measurement and food intake. Eat
a meal or snack within 10 minutes of the bolus dose to avoid low blood sugar. When necessary, you
can take the bolus dose just after you have finished eating.
NovoRapid can be used in adolescents and children aged 1 year and above.
NovoRapid PumpCart is for injection under the skin (subcutaneously) via a pump. Never inject
directly into a vein (intravenously) or muscle (intramuscularly). If necessary NovoRapid can be given
directly into a vein but this must only be done by physicians or other healthcare staff.
Before using NovoRapid PumpCart in a pump, you must have thorough training in the use of the
pump and information about any actions to be taken in case of illness, too high or too low blood sugar
or failure of the pump. Follow your doctors instructions and advice about the use of NovoRapid
PumpCart in the pump.
Normally you will inject your insulin in the front of your waist (abdomen). Alternatively, if your
doctor recommends it, you may use your thigh or upper arm. When you change the infusion set
(tubing and needle), be sure to change the site for inserting the needle (injection site). This may reduce
the risk of developing lumps or skin pitting (see section 4, Possible side effects). Changing the
infusion set must be done according to the instructions in the manual supplied with the infusion set.
When you are using an insulin pump
It is best to measure your blood sugar level regularly, to get the maximum benefit of insulin delivery,
and to make sure the pump is working properly. If you experience any problems contact your doctor.
NovoRapid PumpCart is only for use with a pump designed to be used with this cartridge, such
as the Accu-Chek Insight and YpsoPump insulin pumps.
NovoRapid PumpCart is a pre-filled cartridge ready for use directly in the pump. Follow the
pump manual (user guide).
NovoRapid should never be mixed with any other medicinal product including other insulin
products when used in a pump.
Do not refill the cartridge. Once empty, it must be disposed of.
Always carry a spare NovoRapid PumpCart.
Read carefully the instructions for use included in this package leaflet.
What to do in case of pump failure
Make sure you have an alternative delivery method for your insulin available for injection under the
skin (for example, a pen injector) in case the pump stops working.
107
people.


biscuits, fruit juice) and adjust insulin delivery or stop your pump. Measure your blood sugar if
possible and rest. Always carry glucose tablets or high sugar snacks with you, just in case.
108
people.


Rare side effects

109


5. How to store NovoRapid PumpCart

Do not use this medicine after the expiry date which is stated on the cartridge label and carton, after
Always keep the cartridge in the outer carton when you are not using it in order to protect it from light.
NovoRapid PumpCart must be protected from excessive heat and light during storage and use.
Before opening: NovoRapid PumpCart that is not being used is to be stored in the refrigerator at 2C
to 8C, away from the cooling element. Do not freeze.
During use or when carried as a spare: NovoRapid PumpCart in use is not to be kept in the
refrigerator. NovoRapid PumpCart carried as a spare can be kept for up to 2 weeks below 30C.
Thereafter it can be used for up to 7 days below 37C in a pump designed to be used with this
cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps. Keep NovoRapid PumpCart
in the blister until use to protect it from damage. Always protect the cartridge from light during use.
What NovoRapid PumpCart contains
The active substance is insulin aspart. Each ml contains 100 units of insulin aspart. Each
cartridge contains 160 units of insulin aspart in 1.6 ml solution for injection.
What NovoRapid PumpCart looks like and contents of the pack
NovoRapid PumpCart is presented as a solution for injection.
Pack size of 5 cartridges and a multipack containing 25 (5 packs of 5) cartridges of 1.6 ml. Not all
pack sizes may be marketed.
110
Now turn over for information on how to use your NovoRapid PumpCart.
111
Instructions on how to use NovoRapid PumpCart pre-filled cartridge.
NovoRapid PumpCart is only for use with an insulin infusion pump system designed to be used
with this cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps. It must not be
used with other devices not designed for NovoRapid PumpCart, as this may result in incorrect
insulin dosing and subsequent hyper- or hypoglycaemia.
Please read these instructions carefully before using your NovoRapid PumpCart.
Please also read the pump manual (user guide) that comes with your insulin pump.
NovoRapid PumpCart is ready for use directly in the pump.
NovoRapid PumpCart contains 1.6 ml insulin aspart solution, equivalent to 160 units.
This medicinal product should never be mixed with any other medicinal products.
Do not refill NovoRapid PumpCart. Once empty, it must be disposed of.
Always make sure you have a spare NovoRapid PumpCart available.
NovoRapid PumpCart must be protected from excessive heat and light during storage and use.
NovoRapid PumpCart should be kept out of reach of others, especially children.
A Plunger
White label band
1. Before inserting a NovoRapid PumpCart cartridge into your pump
Bring NovoRapid PumpCart to room temperature.
Take NovoRapid PumpCart out of its blister package.
Check the label to make sure that it is NovoRapid PumpCart.
Check the expiry date, which is stated on the label and the carton.
Always check NovoRapid PumpCart. Do not use it if any damage or leakage is seen or if the
plunger has been drawn above the white label band (picture A). This could be a result of leakage
of insulin. If you suspect NovoRapid PumpCart is damaged, take it back to your supplier.
Check that the insulin in NovoRapid PumpCart is clear and colourless. If the insulin looks
cloudy, do not use NovoRapid PumpCart.
2. Inserting a new NovoRapid PumpCart cartridge in your pump
112
Follow the instructions in the pump user manual that comes with your pump, to insert a new
NovoRapid PumpCart cartridge in your pump.
Insert a NovoRapid PumpCart in the cartridge compartment of the pump. The plunger goes in
first.
Connect the infusion set with NovoRapid PumpCart by attaching the adapter onto your pump.
Follow the instructions in the pump user manual, to continue using your pump.
3. Removing an empty NovoRapid PumpCart cartridge from your pump
Follow the instructions in the pump user manual , to remove an empty NovoRapid PumpCart
cartridge from your pump.
Remove the infusion set adapter from the empty NovoRapid PumpCart cartridge.
Dispose of the empty NovoRapid PumpCart cartridge and the used infusion set as instructed by
your doctor or nurse.
Follow the steps described in section 1 and 2 to prepare and insert a new NovoRapid PumpCart
into your pump.
113

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ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS

NovoRapid 100 units/ml solution for injection in vial

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

NovoRapid FlexPen/NovoRapid InnoLet/NovoRapid FlexTouch

*Insulin aspart is produced in Saccharomyces cerevisiae by recombinant DNA technology.

For the full list of excipients, see section 6.1.

Solution for injection.

The solution is clear, colourless and aqueous.

4.1 Therapeutic indications

4.2 Posology and method of administration

It can also be administered intravenously by physicians or other healthcare staff if applicable.

Elderly ( 65 years old)

Renal and hepatic impairment

Transfer from other insulin medicinal products

NovoRapid is a rapidacting insulin analogue.

Continuous Subcutaneous Insulin Infusion (CSII)

For detailed user instructions, please refer to the package leaflet.

4.4 Special warnings and precautions for use

Inadequate dosing or discontinuation of treatment, especially in type 1 diabetes, may lead to

Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia.

A consequence of the pharmacodynamics of rapid-acting insulin analogues is that if hypoglycaemia

Transfer from other insulin medicinal products

Injection site reactions

Combination of NovoRapid with pioglitazone

Avoidance of accidental mix-ups/medication errors

The following substances may reduce the patient's insulin requirements:

The following substances may increase the patients insulin requirements:

Octreotide/lanreotide may either increase or decrease the insulin requirement.

Alcohol may intensify or reduce the hypoglycaemic effect of insulin.

4.6 Fertility, pregnancy and lactation

4.7 Effects on ability to drive and use machines

4.8 Undesirable effects

Summary of the safety profile

Tabulated list of adverse reactions

Immune system disorders Uncommon Urticaria, rash, eruptions

Very rare Anaphylactic reactions*

Metabolism and nutrition Very common Hypoglycaemia*

Nervous system disorders Rare Peripheral neuropathy (painful neuropathy)

Eye disorders Uncommon Refraction disorders

Uncommon Diabetic retinopathy

Skin and subcutaneous tissue Uncommon Lipodystrophy*

Description of selected adverse reactions

Other special populations

Reporting of suspected adverse reactions

Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary

5.1 Pharmacodynamic properties

Mechanism of action and pharmacodynamic effects

Insulin aspart is equipotent to soluble human insulin on a molar basis.

Elderly ( 65 years old)

5.2 Pharmacokinetic properties

Absorption, distribution and elimination

Elderly ( 65 years old)

5.3 Preclinical safety data

6.1 List of excipients

Substances added to NovoRapid may cause degradation of insulin aspart.

6.3 Shelf life

Before opening: 30 months.

NovoRapid vial/NovoRapid Penfill/NovoRapid FlexPen/NovoRapid InnoLet/NovoRapid FlexTouch

6.4 Special precautions for storage

For storage conditions of the medicinal product, see section 6.3.

Before opening: Store in a refrigerator (2C - 8C). Do not freeze.

NovoRapid FlexPen/NovoRapid InnoLet/NovoRapid FlexTouch